Legal TB-500

plate vi - the record's sources

TB-500 references: every source, indexed.

The peer-reviewed thymosin beta-4 literature and the primary FDA sources behind the legal-status page — checkable, with DOIs, PMIDs, and FDA URLs.

Back to the researchLegal status sources

How to read this list

Each entry below carries the identifier needed to verify it — a PubMed ID, a DOI, an NCT registration number, or an FDA URL. Where an experiment used full-length thymosin beta-4 rather than the TB-500 fragment, that distinction is stated in the body of the relevant page, and most efficacy entries here are full-length-protein studies [5]. The regulatory entries (18 through 23) are the primary and authoritative sources for the legal-status page, drawn from FDA.gov and verified loading on 2026-05-29. The full numbered list renders below.

  1. Irobi E, Aguda AH, Larsson M, et al. Structural basis of actin sequestration by thymosin-beta4: implications for WH2 proteins. EMBO J. 2004;23(18):3599-3608. ↗
  2. Bock-Marquette I, Saxena A, White MD, Dimaio JM, Srivastava D. Thymosin beta4 activates integrin-linked kinase and promotes cardiac cell migration, survival and cardiac repair. Nature. 2004;432(7016):466-472. ↗
  3. Malinda KM, Sidhu GS, Mani H, et al. Thymosin beta4 accelerates wound healing. J Invest Dermatol. 1999;113(3):364-368. ↗
  4. Morris DC, Cui Y, Cheung WL, et al. A dose-response study of thymosin β4 for the treatment of acute stroke. J Neurol Sci. 2014;345(1-2):61-67. ↗
  5. Goldstein AL, Hannappel E, Sosne G, Kleinman HK. Thymosin β4: a multi-functional regenerative peptide. Basic properties and clinical applications. Expert Opin Biol Ther. 2012;12(1):37-51. ↗
  6. Ruff D, Crockford D, Girardi G, Zhang Y. A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin β4 in healthy volunteers. Ann N Y Acad Sci. 2010;1194:223-229. ↗
  7. Smart N, Risebro CA, Melville AAD, et al. Thymosin β4 induces adult epicardial progenitor mobilization and neovascularization. Nature. 2007;445(7124):177-182. ↗
  8. Smart N, Rossdeutsch A, Riley PR. Thymosin β4 and angiogenesis: modes of action and therapeutic potential. Circulation. 2008;117(15):1907-1909. ↗
  9. Bock-Marquette I, Shrivastava S, Srivastava D. Thymosin beta4 is cardioprotective after myocardial infarction. Ann N Y Acad Sci. 2007;1112:343-357. ↗
  10. Stark C, Taimen P, Tarkia M, et al. Cardioprotection by systemic dosing of thymosin beta four following ischemic myocardial injury. Front Pharmacol. 2013;4:149. ↗
  11. ClinicalTrials.gov. Thymosin beta-4 in acute myocardial infarction (NCT05984134), registered as completed; an earlier injectable thymosin β4 acute-stroke trial was withdrawn. (Trial-registry record establishing the absence of completed human efficacy data for the TB-500 fragment.) ↗
  12. Morris DC, Chopp M, Zhang L, Lu M, Zhang ZG. Thymosin beta4 improves functional neurological outcome in a rat model of embolic stroke. Neuroscience. 2010;169(2):674-682. ↗
  13. Peng H, Xu J, Yang XP, et al. Thymosin-β4 prevents cardiac rupture and improves cardiac function in mice with myocardial infarction. Am J Physiol Heart Circ Physiol. 2014;307(5):H741-H751. (Cardiac-rupture / function finding; the tumor-angiogenesis safety signal is reviewed in Goldstein 2012 [5].) ↗
  14. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026. ↗
  15. Sosne G, Qiu P, Kurpakus-Wheater M, et al. Activation of pro-resolving pathways mediate the therapeutic effects of thymosin beta-4. Front Immunol. 2024;15:1458684. ↗
  16. Zhang Y, et al. Tβ4-exosome-loaded hemostatic and antibacterial hydrogel to improve vascularized wound repair. Mater Today Bio. 2025;31:101585. ↗
  17. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. FDA.gov (verified 2026-05-29). Definitions of Category 1 and Category 2 and the bulks-list / nomination framework. ↗
  18. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. FDA.gov. Category 2 entry for 'Thymosin beta-4, fragment (LKKTETQ), also known as TB-500'; effective with the September 29, 2023 update (page verified 2026-05-29). ↗
  19. U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. FDA.gov (verified 2026-05-29). Public calendar listing BPC-157, KPV, TB-500, and MOTs-C as substances 'being considered for inclusion on the 503A Bulks List' — a scheduled discussion, not a decision. ↗
  20. U.S. Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FD&C Act (guidance landing page). FDA.gov (guidance finalized January 2025; verified 2026-05-29). Underlies the January 7, 2025 change to how nominated bulk substances are categorized, and the 503A/503B access framework. ↗
  21. McDermott Will & Emery. End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists. mcdermottlaw.com (analysis of the January 7, 2025 FDA action; verified 2026-05-29). Secondary legal analysis confirming that existing Category 1 substances retain enforcement discretion while Category 2 substances do not regain it. ↗
  22. World Anti-Doping Agency. The Prohibited List. wada-ama.org. TB-500 and thymosin beta-4 fall under prohibited peptide, growth-factor, and tissue-repair categories, banned in and out of competition; detected by LC-MS anti-doping assays in equine and human matrices. ↗